Medicines regulatory agencies face enormous challenges in supporting and maintaining the safety, quality and supply of therapeutic goods in their respective countries and regions. Professor Anthony (Tony) Lawler, head of Australia’s Therapeutic Goods Administration (TGA), took time out from this work to respond to questions regarding the progress that TGA is making on national regulatory and quality issues and his aspirations for the TGA for 2026. This conversation, with the University of New South Wales’s Richard Day, was first published in the May 2026 edition of DIA’s Global Forum magazine.
RD: The TGA website has had a major update completed in 2025. How has this been received?TL: Feedback so far has been positive. The changes we made were based on user testing and feedback, and we reorganized industry information for easier access based on their needs. We added the Product Regulation section, which organizes content by product type, and introduced Business Services for quick TGA Business Service access. The Safety and Shortages section now has clearer pathways for reporting problems and the What’s New feature lists recent website changes in one place.
Reinforcing this positive feedback, in November 2025, we observed a 5% increase in users reporting being “very satisfied” with our website and a 10% rise in users indicating they are “very likely” to revisit compared to the months leading up to the changes. Qualitative feedback has also been positive, including responses such as “Improvements to the website layout are useful and meaningful” and “Fantastic improvement.”
Websites require ongoing maintenance and regular review, and we continue this work behind the scenes to keep the site healthy, secure, and up to date.
RD: The TGA has called for responses to its “Proposed changes to labeling of medicines supplied in Australia,” with the consultation closing on 23 March. What was the rationale for these changes?
TL: The TGA’s labeling orders for prescription and nonprescription medicines, TGOs No. 91 and 92 respectively, will sunset on 1 October 2026. While these are still effective, some areas for improvement have been identified. These include ensuring that the requirements reflect current accepted practice and meet technological and community expectations through, for example, the use of QR codes. New instruments will replace them before they sunset following robust public consultation, incorporating changes where appropriate.
These proposed changes are designed to ensure that medicines are used correctly and safely by healthcare practitioners and consumers, and to provide clearer guidance to sponsors. For example, we are considering separating the guidance for prescription and nonprescription medicines to improve clarity and ease of use. Consistent with sector feedback, we also intend to include more example labels, demonstrating what is and is not acceptable.
